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Sunday, April 2, 2017

Drugs and Devices

          This entry is about my thoughts regarding medical treatment using drugs compared to medical treatment using devices (generally speaking, implanted devices).  First, some personal background so that you can see my biases.  I work in the implantable medical device field, so naturally I am biased towards them.  I have seen firsthand the impact that they can have – not only for the implant recipients I see at work, but also in my own family.  However, I personally do not have a device implanted inside me (yet!) – unless you count the pencil lead lodged in my thigh from an accident in second grade; or the small hunk of metal in my thumb from changing a tire in my rusted out Galaxy 500.  I have had electrodes implanted in my forearm and hand for various testing purposes, but they were just temporary.  I don’t like surgery – but who does?  Also, I’ve never been on any regular medication for anything other than the occasional antibiotic and various NSAIDS and cold medications.  So - that's my background.

          In general, devices are the option of last resort in medical treatment today.  By that I mean that the practice of medicine is designed to try to treat any disease with medications first, generally proceeding from the “least intense” to the “most intense” medication.  Along with treatment via medication, there will also be treatment via non-invasive therapies.  For example, if you have back pain, it will first be treated with some therapy (exercises and so on) and NSAIDS.  As it gets more intense, you will progress to more intense painkillers.  Eventually you may be prescribed an opiate.  If you fail all of those, then you might get back surgery.  And if you fail that, you might get an implanted device called a “spinal cord stimulator” (SCS) device for pain relief.  Of course the treatment path is not always linear, and it varies from specialty to specialty, but in essentially any case, the device is the last resort.

          Because of the field of research I am in, I frequently have the opportunity to talk to disabled individuals about their interest in having a device implanted in them to improve their function and independence.  Occasionally I come across someone who says that they never want to have a device implanted inside them.  At first I thought that it was because they didn’t want to go through surgery again, which is fully understandable.  But no, they are often willing to undergo surgery if it would help, just not have a device inside of them.  I found that to be rather interesting.  I hope they never need a pacemaker!

          To me, it comes down to this:  we are more afraid of what we can see than what we can’t see.  If you take an x-ray of someone who has a device implanted in their body, you’ll see the device plain as day.  It is obviously “unnatural” and that is rather unnerving to all of us.  If we see an x-ray somewhere that shows a lot of “hardware” inside of a person, we’re likely to be thankful that is not our x-ray.

          By contrast, if you take an x-ray of someone who is fully addicted to pain-killers, you won’t see anything different.  Even if you take an MRI, you won’t see anything different.  In fact, even if you take their brain, dissect it apart, and examine the individual neurons, you still might not see the addiction itself.  It is, for all intents and purposes, invisible to us.  For most of us, the effect of most drugs on our body is never immediately visible.  And so…it seems safe.  Even if we drink a bit of a poison like arsenic, there may be no immediate effect.  But it has effectively invaded every cell of our body.  We can’t get rid of it.

          The reality is that drugs are frequently more dangerous to us than any device.  Are there any drugs that do not have side-effects?  Often, a second drug is added to reverse the side-effects of the first drug, and so on.  We accept the side-effects because it seems like an acceptable trade-off if we get the relief we are seeking from our primary symptoms.  The problem is that some of the most serious side-effects are very slow developing.  Drugs that increase the likelihood of getting cancer, or damage our liver, are usually very slow acting and those more serious side-effects do not become apparent until years, even decades, later.  By then it is too late.  In those cases, you can’t reverse or even treat the effects.  If you stop taking the drug, you may still be left with its side-effects – sometimes for the rest of your life.

          To be sure, there are some potential “side-effects” of devices.  The most common disadvantage with any implanted device is the risk of infection.  On rare occasions devices move inside the body, or some part breaks and it no longer works.  But, the point is, these are fixable problems because, in the worst case, the device can be removed to resolve the problem.  The thing that seems the scariest to us – the fact that we can see it on an x-ray – also makes it inherently safer.  If we can see it, we can remove it and get rid of it.  In most cases a device can be removed without any further consequences.

          Another apparent disadvantage of devices is their initial expense.  Because they involve surgery, and they are often very expensive themselves, the whole cost of getting a device can be quite high.  Insurance companies are reluctant to pay that up-front cost.  They would rather pay monthly for drugs you have to take daily than to pay for the one-time cost of implanting a device.  There is an aspect of human nature that would rather spend $5/day every day for the rest of their life than to pay $5,000 now and be done with it.  Often the math clearly comes out in the favor of the device, particularly if it is more effective than the drug, but that is usually ignored.  In that sense, we seem to prefer the “death by a thousand cuts”, though maybe that is a poor idiom to use in this case!

          The point is that since devices are nearly always relegated to the “last resort”, it means we all have to first live through the side effects of drugs before a device will be considered for treatment.  However, there are certain situations where that leads to two major disadvantages.  First, we are stuck with the side-effects of the drug, and some of those side-effects are difficult, if not impossible, to reverse.  Second, by the time a device is utilized for treatment, the disease has progressed to the point where it is much more difficult to treat by any means.  Thus a device, which might have provided relief at an earlier stage, can no longer provide any relief.  There is even some evidence that if devices were used at an earlier stage, they might halt or even reverse the progression of the disease.

          Medical devices do have to be made safer, smaller, less-invasive and more effective.  They are certainly not always the answer.  But there are cases where progression to treatment with a device is better for the patient and is more cost-effective, than continued treatment with drugs.  For example, our current health care system is set up to keep treating chronic pain with opiates until the person is potentially addicted, before considering treatment with a device like a spinal cord stimulator.  The device is not always the solution, but there is evidence that the device would be more effective if it were used earlier, and it does not have near the negative personal, social, and financial consequences that opiate addiction has. 

My point is that medical devices should be given a fair consideration in the treatment of various diseases and disabilities, and not always relegated to the “last resort.”  This is a significant change in thinking.  First, the practice of medicine will have to be convinced of the potential of devices to be more than a last resort in certain situations.  Second, the reimbursement structure will have to change to reflect this difference in thinking.  And, finally, the perception of devices by the general public as being more invasive than drugs will have to be adjusted.  Each one of these steps is a major undertaking.  It will certainly not happen overnight and probably not in my lifetime.  But I do think that eventually the general perception will change on this issue.

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